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Effect of Shockwave Therapy on Post-laminectomy Fibrosis Low Back Pain Patients. (SWT)

Primary Purpose

Post-laminectomy Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Radial Extracorporeal Shock wave Therapy
Transcutaneous Electrical Nerve Stimulation (TENS)
McKenzie Back exercises
electric heating pads
Sponsored by
Marwa Mohamed Hany Sedeek Abousenna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-laminectomy Syndrome focused on measuring Sciatica, low back pain, post-laminectomy syndrome, Radial Shock Wave Therapy

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Recruited patients will be diagnosed by neurosurgeon as sciatic pain and low back pain caused by post laminectomy scarring. Both genders will be recruited. Their age will range from: 30-50 years (Sharaf, et al., 2022). Recruited patients will be randomly assigned in to two equal groups. Unilateral radicular sciatica. Constant back pain OR aggravated by movement, Restricted lumbar range of motion. Tenderness at the site of incision. Duration of symptoms: three weeks to six months postoperatively Exclusion Criteria: Past history of vertebral fracture. Spinal cord compression. Vertebral tuberculosis. Polyneuropathy. Diabetic peripheral neuropathy. Spinal tumor. Recurrent disc herniation after surgery. Spondylolisthesis. Vascular diseases, e.g., peripheral vascular diseases, coronary artery bypass graft and coagulation diseases. Potential pregnancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Active Comparator

    Arm Label

    controlled

    shock wave therapy

    Arm Description

    thirty patients will receive conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).

    thirty patients will receive radial extracorporeal shock wave therapy and conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).

    Outcomes

    Primary Outcome Measures

    Visual Analogue Scale (VAS)
    The VAS consisted of a 10 cm horizontal line with the description "no pain" on the far left and "worst possible pain" on the far right

    Secondary Outcome Measures

    Pain algometry
    PainTest™ FPX 25 Algometer (Wagner Instruments, Greenwich, USA)
    Lumbar Range Of Motion
    The BROM II
    The Oswestry Disability Index: (ODI)
    The Oswestry disability index is a self-completed, valid tool with adequate reliability to identify changes in functional disability
    Sensory Nerve Conduction Study (NCS)
    Sensory nerve action potentials (sensory nerve amplitude)

    Full Information

    First Posted
    April 28, 2023
    Last Updated
    May 31, 2023
    Sponsor
    Marwa Mohamed Hany Sedeek Abousenna
    Collaborators
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05887024
    Brief Title
    Effect of Shockwave Therapy on Post-laminectomy Fibrosis Low Back Pain Patients.
    Acronym
    SWT
    Official Title
    Effect of Shock Wave Therapy on Low Back Pain and Sciatica in Patients With Post-laminectomy Fibrosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    May 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Marwa Mohamed Hany Sedeek Abousenna
    Collaborators
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study is clinical trial to investigate the effect of Radial Extracorporeal Shock wave therapy in patients with sciatica and low back pain caused by post laminectomy scarring. the study will answer the following question: 1. what is the effect of Shock Wave Therapy on low back pain and sciatica caused by post-laminectomy fibrosis? patients in the study group will receive radial extracorporeal shock wave therapy and conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-laminectomy Syndrome
    Keywords
    Sciatica, low back pain, post-laminectomy syndrome, Radial Shock Wave Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A. Control group (Group A) thirty patients will receive conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises). B. Study group (Group B) thirty patients will receive radial extracorporeal shock wave therapy and conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).
    Masking
    Participant
    Masking Description
    The selected patients will be allocated by computerized block randomization.
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    controlled
    Arm Type
    Other
    Arm Description
    thirty patients will receive conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).
    Arm Title
    shock wave therapy
    Arm Type
    Active Comparator
    Arm Description
    thirty patients will receive radial extracorporeal shock wave therapy and conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).
    Intervention Type
    Device
    Intervention Name(s)
    Radial Extracorporeal Shock wave Therapy
    Intervention Description
    Shock wave therapy: (BECO) S/N 16B011375
    Intervention Type
    Device
    Intervention Name(s)
    Transcutaneous Electrical Nerve Stimulation (TENS)
    Intervention Description
    EME (Therapic 9400) TENS
    Intervention Type
    Procedure
    Intervention Name(s)
    McKenzie Back exercises
    Intervention Description
    Graduated Progressive back exercise program.
    Intervention Type
    Device
    Intervention Name(s)
    electric heating pads
    Intervention Description
    electrical conducting heat pack.
    Primary Outcome Measure Information:
    Title
    Visual Analogue Scale (VAS)
    Description
    The VAS consisted of a 10 cm horizontal line with the description "no pain" on the far left and "worst possible pain" on the far right
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Pain algometry
    Description
    PainTest™ FPX 25 Algometer (Wagner Instruments, Greenwich, USA)
    Time Frame
    4 weeks
    Title
    Lumbar Range Of Motion
    Description
    The BROM II
    Time Frame
    4 weeks
    Title
    The Oswestry Disability Index: (ODI)
    Description
    The Oswestry disability index is a self-completed, valid tool with adequate reliability to identify changes in functional disability
    Time Frame
    4 weeks
    Title
    Sensory Nerve Conduction Study (NCS)
    Description
    Sensory nerve action potentials (sensory nerve amplitude)
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Recruited patients will be diagnosed by neurosurgeon as sciatic pain and low back pain caused by post laminectomy scarring. Both genders will be recruited. Their age will range from: 30-50 years (Sharaf, et al., 2022). Recruited patients will be randomly assigned in to two equal groups. Unilateral radicular sciatica. Constant back pain OR aggravated by movement, Restricted lumbar range of motion. Tenderness at the site of incision. Duration of symptoms: three weeks to six months postoperatively Exclusion Criteria: Past history of vertebral fracture. Spinal cord compression. Vertebral tuberculosis. Polyneuropathy. Diabetic peripheral neuropathy. Spinal tumor. Recurrent disc herniation after surgery. Spondylolisthesis. Vascular diseases, e.g., peripheral vascular diseases, coronary artery bypass graft and coagulation diseases. Potential pregnancy.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The IPD will be free to share within 6 months to 1 year after publication.
    IPD Sharing Time Frame
    6 months to 1 year after publication.

    Learn more about this trial

    Effect of Shockwave Therapy on Post-laminectomy Fibrosis Low Back Pain Patients.

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